T2 Biosystems Inc

FDA Filings

This page includes the latest FDA filings for T2 Biosystems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQTTOODUNS 803126320
FDA Registration(s)
Registration Number3010097867
FEI Number3010097867
NameT2 BIOSYSTEMS, INC.
Owner & OperatorT2 Biosystems, Inc.
Contact Address101 Hartwell Avenue
Lexington MA 02421 US
Official Correspondent
  • Tom Lowery
  • 1-781-4571223-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address101 Hartwell Ave
Lexington, MA 02421 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
T2 BIOSYSTEMS, INC.
T2Candida® Reagent Trays 2024-09-19
T2 BIOSYSTEMS, INC.
T2Bacteria® QCheck Positive Kit 2024-02-28
T2 BIOSYSTEMS, INC.
T2Bacteria® Reagent Trays 2024-02-28
T2 BIOSYSTEMS, INC.
T2Bacteria® QCheck Negative Kit 2024-02-16
T2 BIOSYSTEMS, INC.
T2Biothreat® QCheck Negative Kit 2023-11-15
T2 BIOSYSTEMS, INC.
T2Biothreat® QCheck Positive Kit 2023-11-15
T2 BIOSYSTEMS, INC.
T2Biothreat® Reagent Trays 2023-11-15
T2 BIOSYSTEMS, INC.
T2Dx® 2022-09-16
T2 BIOSYSTEMS, INC.
T2Candida® Cartridge Kit 2022-04-28
T2 BIOSYSTEMS, INC.
T2Bacteria® Cartridge Kit 2020-12-21
T2 BIOSYSTEMS, INC.
T2Bacteria® Reagent Trays 2020-12-21
T2 BIOSYSTEMS, INC.
T2Dx® QCheck Negative Kit 2020-02-26
T2 BIOSYSTEMS, INC.
T2Dx® QCheck Negative Kit 2020-02-19
T2 BIOSYSTEMS, INC.
T2Candida 1.1 Panel2018-06-22
T2 BIOSYSTEMS, INC.
T2Bacteria Panel2018-06-22
T2 BIOSYSTEMS, INC.
T2Bacteria Panel2018-06-22
T2 Biosystems, Inc.
T2Bacteria Panel2018-05-24
T2 Biosystems, Inc.
T2Candida 1.1 Panel2017-12-12
T2 BIOSYSTEMS, INC.
T2Dx Instrument2015-04-06
T2 BIOSYSTEMS, INC.
T2Candida Panel2015-04-06
T2 BIOSYSTEMS, INC.
T2Bacteria Panel2015-04-06
T2 BIOSYSTEMS, INC.
T2Dx Instrument2015-04-06
T2 BIOSYSTEMS, INC.
T2Candida Panel2015-04-06
T2 BIOSYSTEMS, INC.
T2Bacteria Panel2015-04-06
T2 BIOSYSTEMS, INC
T2CANDIDA AND T2DX INSTRUMENT2014-09-22

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